This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|January 28, 2026
Streamline Microbial Process Development to Reach GMP Faster
Author(s)FUJIFILM Biotechnologies
This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined, cost-effective path that accelerates development from strain selection through tox material and early GMP, to reach IND and first-in-human trials faster.
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